Instrumentation Scientist II

at  Thermo Fisher Scientific

SUMMARY:

Calibrates and qualifies all new and existing analytical equipment according to a set schedule and current Patheon Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and corporate quality standards.

EDUCATION:

Community College in Chemistry or related field
B.Sc. in chemistry or a related field an asset.

EXPERIENCE:

Minimum 3 years of instrumentation validation experience in a pharmaceutical industry or related field.
Minimum of 2 years of experience performing analytical testing as assigned for on prototype to commercial batches supporting development and/or manufacturing operations OR
Minimum 1 year demonstrated proficiency as an Instrumentation Scientist I
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, and Abilities:
Good understanding of basic chemistry and experience with common laboratory equipment and operation. Knowledge of Good Lab Practices and Good Manufacturing Practices. Strong computer proficiency with lab software and Microsoft (MS) Office programs. Excellent communication skills (both oral and written). Ability to meet deadlines and prioritize. Detail oriented with excellent organizational skills. Good understanding of quality and regulatory requirements in the pharmaceutical industry. Good problem-solving skills and logical approach to solving problems. Ability to meet deadlines and prioritize work. Works well in a team environment and cooperates with other members of the team to find a solution. Self-motivated with the ability to meet multiple deadlines. Proficiency with the English Language.

PHYSICAL REQUIREMENTS:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Use of Personal Protective equipment may be required and may include any of the following: Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally

• Conducts maintenance and calibrations for each new and existing piece of analytical equipment in accordance with a schedule. Meets standard hours for tasks assigned.
• Troubleshoots and repairs malfunctioning apparatus independently.
• Maintains detailed and accurate records to meet all regulatory and user requirements.
• Proficiency with Trackwise to open and close change control activities.
• Follows all current SOPs and procedures.
• Maintains a safe working environment and reports potential hazards.
• Limited travel to other local sites (as required)
• Ability to respond to emergency after-hours (as required)
• Perform alternating or rotating shift work (as required)